Kitabis Pak (Page 4 of 5)

15 REFERENCES

  1. Neu HC. Tobramycin: an overview. [Review]. J Infect Dis 1976; Suppl 134:S3-19.
  2. Weber A, Smith A, Williams-Warren J et al. Nebulizer delivery of tobramycin to the lower respiratory tract. Pediatr Pulmonol 1994; 17 (5):331-9.
  3. Bryan LE. Aminoglycoside resistance. Bryan LE, Ed. Antimicrobial drug resistance. Orlando, FL: Academic Press, 1984: 241-77.
  4. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard — Ninth Edition. CLSI document M07-A9, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
  5. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Eleventh Edition. CLSI document M02-A11, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
  6. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fourth Informational Supplement , CLSI document M100-S24, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2014.

16 HOW SUPPLIED / STORAGE AND HANDLING

16.1 How Supplied

KITABIS PAK co-packaged kit (NDC 70644-899-99) is available in cartons containing one reusable PARI LC PLUS nebulizer (Model No.: 022B81-TA) and 14 tobramycin inhalation solution pouches. Each pouch contains four 300 mg/5 ml ampules of tobramycin inhalation solution for a total of 56 ampules in each carton. Each carton constitutes a 28 day supply.

16.2 Storage

  • Tobramycin inhalation solution should be stored under refrigeration at 2-8°C/36-46°F. Upon removal from the refrigerator, or if refrigeration is unavailable, tobramycin inhalation solution pouches (opened or unopened) may be stored at room temperature (up to 25°C/77°F) for up to 28 days. Tobramycin inhalation solution should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (2-8°C/36-46°F) or beyond 28 days when stored at room temperature (25°C/77°F).
  • Tobramycin inhalation solution ampules should not be exposed to intense light. The solution in the ampule is slightly yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Instructions for Administration

Instruct patients to read the Instructions for Use before starting KITABIS PAK. Instruct patients to use the tobramycin inhalation solution in KITABIS PAK only with the PARI LC PLUS Reusable Nebulizer included in the KITABIS PAK.

Difficulty Breathing

Advise patients to inform their physicians if they experience shortness of breath or wheezing after administration of tobramycin inhalation solution. Tobramycin inhalation solution can cause a narrowing of the airway [see Warnings and Precautions (5.1)].

Hearing Loss

Advise patients to inform their physician if they experience ringing in the ears, dizziness, or any changes in hearing because tobramycin inhalation solution has been associated with hearing loss [see Warnings and Precautions (5.2)].

Kidney Damage

Advise patients to inform their physician if they have any history of kidney problems because tobramycin inhalation solution is in a class of drugs that have caused kidney damage [see Warnings and Precautions (5.3)].

Embryo-Fetal Toxicity:

Advise pregnant women that aminoglycosides can cause irreversible congenital deafness when administered to a pregnant woman [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1)].

Lactation:

Advise a woman to monitor their breastfed infants for diarrhea and/or bloody stools [see Use in Specific Populations (8.2)].

Additional Information

PARI LC PLUS® Reusable Nebulizer: 1-800-327-8632

DeVilbiss® Pulmo-Aide® Air Compressor: 1-800-338-1988

KITABIS PAK: 1-844-KITABIS (548-2247)

Manufactured by:

Catalent Pharma Solutions, LLC Woodstock, IL 60098

Logo

Distributed by: PARI Respiratory Equipment, Inc. 2412 PARI Way, Midlothian, VA 23112

850D5601Rev. D 11/2019

© 2013-2019 PulmoFlow, Inc. All rights reserved.

PATIENT INFORMATION KITABIS® PAK (Ki TAH biss Pak) (tobramycin inhalation solution) for oral inhalation
Read this Patient Information before you start using KITABIS PAK and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is KITABIS PAK? KITABIS PAK contains a prescription medicine and a PARI LC PLUS Reusable Nebulizer used to treat adults and children 6 years of age and older with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa. KITABIS PAK contains an antibacterial medicine called tobramycin (an aminoglycoside).It is not known if tobramycin inhalation solution is safe and effective:
  • in children under 6 years of age.
  • in people who have an FEV1 less than 25% or greater than 75% predicted.
  • in people who are colonized with a bacterium called Burkholderia cepacian.
  • when used for more than 3 cycles.
Who should not use KITABIS PAK? Do not use KITABIS PAK if you are allergic to tobramycin, any of the ingredients in KITABIS PAK, or to any other aminoglycoside antibacterial medicine.
What should I tell my healthcare provider before using KITABIS PAK?Before using KITABIS PAK, tell your healthcare provider about all of your medical conditions, including if you:
  • have or have had breathing problems such as wheezing, coughing, or chest tightness.
  • have or have had hearing problems (including noises in your ears).
  • have dizziness.
  • have or have had kidney problems.
  • have or have had problems with muscle weakness such as myasthenia gravis or Parkinson’s disease.
  • are pregnant or plan to become pregnant. KITABIS PAK contains a medicine that may cause harm to your unborn baby. See “What are the possible side effects of KITABIS PAK?” below for more information.
  • are breastfeeding or plan to breastfeed. It is not known if the medicine in KITABIS PAK (tobramycin inhalation solution) passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter, vitamins, and herbal supplements.Using KITABIS PAK with certain other medicines can cause serious side effects. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.If you are using KITABIS PAK, you should discuss with your healthcare provider if you should take:
  • other medicines that may harm your nervous system, kidneys, or hearing
  • “water pills” (diuretics) such as Edecrin (ethacrynic acid), Lasix (furosemide), or mannitol
  • urea
How should I use KITABIS PAK?
  • See the step-by-step Instructions for Use at the end of this Patient Information leaflet about the right way to use KITABIS PAK.
  • Use KITABIS PAK exactly as your healthcare provider tells you to. Ask your healthcare provider or pharmacist if you are not sure.
  • The usual dose of KITABIS PAK for adults and children 6 years of age and over is:
    • 1 ampule of tobramycin inhalation solution inhaled by mouth in the morning and 1 ampule of tobramycin inhalation solution inhaled by mouth in the evening using your PARI LC PLUS Reusable Nebulizer with a DeVilbiss® Pulmo-Aide air compressor.
  • Each dose of KITABIS PAK should take about 15 minutes to finish.
  • Each dose of KITABIS PAK should be used as close to 12 hours apart as possible.
  • Do not use your dose of KITABIS PAK less than 6 hours apart.
  • After using KITABIS PAK for 28 days, you should stop using it for 28 days. After you have stopped using KITABIS PAK for 28 days, you should start using KITABIS PAK again for 28 days. It is important that you keep to the 28-day on, 28-day off cycle.
  • Do not mix the medicine in KITABIS PAK with other medicines including dornase alfa in your nebulizer.
  • If you are taking other medicines inhaled through your mouth (bronchodilators), your healthcare provider will tell you how to take your medicine the right way.
  • If you inhale too much of the medicine in KITABIS PAK, tell your healthcare provider right away.
What are the possible side effects of KITABIS PAK?KITABIS PAK can cause serious side effects, including:
  • severe breathing problems (bronchospasm). Tell your healthcare provider right away if you get any of these symptoms of bronchospasm while using KITABIS PAK:
    • shortness of breath with wheezing
    • coughing and chest tightness
  • hearing loss or ringing in the ears (ototoxicity). Tell your healthcare provider right away if you have hearing loss or hear noises in your ears (such as ringing or hissing), or if you develop vertigo, dizziness, or difficulty with balance.
  • worsening kidney problems (nephrotoxicity). Your healthcare provider may do a blood test and urine test to check how your kidneys are working while you are using KITABIS PAK.
  • worsening muscle weakness. The medicine in KITABIS PAK (tobramycin inhalation solution) is in a class of medicines that can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis or Parkinson’s disease).
  • The medicine in KITABIS PAK (tobramycin inhalation solution) is in a class of medicines which may cause harm to an unborn baby.
The most common side effects of KITABIS PAK include:
  • cough
  • sore throat
  • productive cough
  • shortness of breath
  • coughing up blood
  • worsening of lung problems or cystic fibrosis
  • changes in your voice (hoarseness)
  • altered taste
  • rash
These are not all of the possible side effects of KITABIS PAK. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of KITABIS PAK. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use KITABIS PAK for a condition for which it was not prescribed. Do not give KITABIS PAK to other people, even if they have the same symptoms that you have. It may harm them.You can ask your healthcare provider or pharmacist for information about KITABIS PAK that is written for health professionals.
What are the ingredients in KITABIS PAK? Active ingredient: tobramycinInactive ingredients: sodium chloride in sterile water, sulfuric acid, and sodium hydroxide (for pH adjustment)

INSTRUCTIONS FOR USE

KITABIS PAK (Ki TAH biss Pak)

(tobramycin inhalation solution), for oral inhalation

Follow the instructions below for using KITABIS PAK which contains tobramycin inhalation solution and the PARI LC PLUS Reusable Nebulizer (PARI LC PLUS). If you have any questions, ask your healthcare provider or pharmacist.

Each KITABIS PAK carton (28-day supply) contains 56 tobramycin inhalation solution ampules packed in 14 foil pouches that each contain 4 singleuse tobramycin inhalation solution ampules.

You will need the following supplies (See Figure A):

  • 1 tobramycin inhalation solution ampule
  • PARI LC PLUS Reusable Nebulizer
  • DeVilbiss Pulmo-Aide (Pulmo-Aide) air compressor
  • tubing to connect the nebulizer and compressor
  • clean, lint-free towel
  • nose clip (optional, not pictured)

Figure

Note: Read the Instructions for Use that come with your PARI LC PLUS Reusable Nebulizer and DeVilbiss Pulmo-Aide air compressor for detailed instructions on how to use and care for your nebulizer and air compressor before you use it.

Do not mix the medicine in KITABIS PAK with other medicines in your nebulizer.

The medicine in KITABIS PAK (tobramycin inhalation solution) comes in a sealed foil pouch. Do not open a sealed pouch until you are ready to use a dose. After opening the pouch, unopened ampules should be returned to and stored in the pouch.

Getting ready:

  • Open the PARI LC PLUS package. Place the PARI LC PLUS parts including Top and Bottom (Nebulizer Cup) Assembly, Inspiratory Valve Cap, Mouthpiece with Valve, and Tubing on a clean, dry surface or towel (See Figure B).

Figure

Preparing your KITABIS PAK dose:

Step 1: Wash your hands with soap and water (See Figure C).

Figure

Step 2: Open the foil pouch (See Figure D).

Figure

Step 3: Separate 1 ampule by gently pulling apart starting at the top of the ampules and continue down to the bottom tabs (See Figure E) and use it right away.

Figure

Step 4: Hold the bottom tab on the KITABIS PAK ampule with 1 hand (See Figure F). With your other hand, hold the top of the ampule and twist off the top of the ampule (See Figure F).

  • Do not squeeze the ampule until you are ready to squeeze all of the medicine into the Nebulizer Cup.

Figure

Step 5: Hold the Nebulizer Cup and twist off the Nebulizer Insert or Top in a counter-clockwise direction (See Figure G). Set the Top aside on a clean, dry, surface.

Figure

Step 6: Squeeze all the medicine from the ampule into the Nebulizer Cup (See Figure H).

Figure

Step 7: Replace the Nebulizer Insert. Line up the semicircle on the Nebulizer Insert with the Nebulizer Outlet and twist on the Nebulizer Insert in a clockwise direction until it is tight and the alignment rings are lined up (See Figure I).

Figure

Step 8: Push the Mouthpiece straight onto the Nebulizer Cup (See Figure J).

Figure

Step 9: Firmly push the Inspiratory Valve Cap straight down onto the Nebulizer Cup Top (See Figure K). The Inspiratory Valve Cap should fit tightly.

Figure

Step 10: Connect 1 end of the tubing to the compressor air outlet (See Figure L). The tubing should fit tightly.

Figure

Step 11: Plug your compressor into an electrical outlet (See Figure M).

Figure

Step 12: Hold the Nebulizer Cup upright and firmly push the free end of the tubing straight up onto the Air Intake on the bottom of the Nebulizer Cup (See Figure N). Make sure to keep the Nebulizer Cup upright.

Figure

Giving your KITABIS PAK dose:

Step 13: Turn on the compressor (See Figure O). You should see a steady mist coming from the Mouthpiece (See Figure P).

Figure

Step 14: Sit or stand in a comfortable, upright position that will allow you to breathe normally. Place the Mouthpiece between your teeth and on top of your tongue and breathe normally only through your mouth (See Figure Q).

  • Nose clips may help you breathe only through your mouth and not through your nose.

Figure

Step 15: Keep breathing in your KITABIS PAK dose for at least 15 minutes. You will know that you have received your full dose of medicine when you hear a “sputtering noise” coming from the Mouthpiece for at least 1 minute and the Nebulizer Cup is empty.

After your KITABIS PAK dose:

Step 16: Clean and disinfect your nebulizer (see manufacturer’s Instructions for Use).

Care and Use of your DeVilbiss Pulmo-Aide compressor:

Follow the manufacturer’s instructions for care and use of your compressor.

How should I store KITABIS PAK?

  • Store tobramycin inhalation solution in the refrigerator between 36°F to 46°F (2°C to 8°C) until needed.
  • You may store the tobramycin inhalation solution in the foil pouches (opened or unopened) at room temperature between 68°F to 77°F (20°C to 25°C) for up to 28 days.
  • Do not use tobramycin inhalation solution after the expiration date stamped on the ampule.
  • Keep tobramycin inhalation solution in the foil pouch and out of the light.
  • Tobramycin inhalation solution is normally slightly yellow, but may get darker with age if unrefrigerated. The color change does not change how the medicine works.
  • Do not use tobramycin inhalation solution if it is cloudy, has particles in the solution, or if it has been stored at room temperature for more than 28 days. Throw the applicable ampule(s) away in your household trash and get a new ampule.

Keep KITABIS PAK and all medicines out of the reach of children.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Revised: DATE

Additional Information

PARI LC PLUS® Reusable Nebulizer: 1-800-327-8632
DeVilbiss® Pulmo-Aide® Air Compressor: 1-800-338-1988
KITABIS PAK: 1-844-KITABIS (548-2247)

Manufactured by:

Catalent Pharma Solutions, LLC Woodstock, IL 60098

Figure

Distributed by: PARI Respiratory Equipment, Inc. 2412 PARI Way, Midlothian, VA 23112

850D5601 Rev. D 11/2019© 2013-2019 PulmoFlow, Inc. All rights reserved.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.